Infant formula: Alternative protein study and regulatory roadmap

We are **Grow with Iris**. In spring 2024 we are launching a plant-based, free from, fortified growing up drink for children aged 12 months plus. We are made specifically for immunocompromised and plant-based children. Co-founder Amy's daughter Iris lives with numerous food allergies and is our inspiration.

Our ultimate goal is to create a plant-based, hypoallergenic infant formula to provide a universal, off-the-shelf, nutritionally capable option. It would enable babies needing alternative diets to thrive, especially infants unable to be breastfeed. Our innovation is vital if the UK is to deliver inclusive feeding options. However, there is currently no hypoallergenic protein registered for use in infant formula. We aim to become a world-changing, market contender, but there are no shortcuts in terms of robust evidence to support safe and efficacious infant nutrition products and the supporting regulatory authorisation.

This project is the first of several innovative steps required to gain the registration of an alternative, hypoallergenic protein for use in infant formula. It would lead on to further innovative work including an authorisation dossier and clinical trial to prove validation of suitability and growth, before we could work on the protein source authorisation and eventual registration in target markets (UK, EU, US) to enable us to commercialise our products.

Our project will draw together leading experts in academia, clinical, government and industry fields to produce a feasibility study and regulatory roadmap to explore suitability, ensure efficacy and safety and will support regulatory authorisation to access markets. As part of the study, we would find the most suitable plant-based source of protein. A scientific workshop will be convened to review gathered evidence and data package proposals to provide validation and the outputs published. It aims to inform government food/healthcare strategy, highlighting more inclusive nutrition options for infants.

Our publishable study could become a catalyst -- opening up more research opportunities, creating a shift in thinking about alternative proteins, future government health strategies and the knowledge of healthcare, medical professionals and the public. The government food strategy review suggests policy initiatives should boost health, sustainability, accessibility of diets and secure food supply that "Delivers safe, healthy, affordable food; regardless of where (people) live or how much they earn." With cow's milk being the most common global food allergy in children and a growing trend in plant-based living, change is needed to challenge and disrupt a static industry and the current limited options.